FDA Clears New Combo Pill Genvoya for HIV-1 Infection

Megan Brooks

Disclosures

November 05, 2015

The US Food and Drug Administration (FDA) has approved a fixed-dose combination tablet containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (Genvoya, Gilead Sciences) for the treatment of HIV-1 infection.

Genvoya is approved for HIV-infected treatment-naive adults and children aged 12 years and older weighing at least 35 kg and for adults whose HIV-1 is currently suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen.

The safety and efficacy of Genvoya were evaluated in 3171 adults enrolled in four clinical trials. "Results showed Genvoya was effective in reducing viral loads and comparable to the other treatment regimens," the FDA said.

"Today's approval of a fixed dose combination containing a new form of tenofovir provides another effective, once daily complete regimen for patients with HIV-1 infection," Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a news release.

Tenofovir alafenamide (TAF) is a novel targeted prodrug of tenofovir that has high antiviral efficacy similar to and at a dose less than one tenth that of Gilead's tenofovir disoproxil fumarate (Viread), the company notes in a news release.

TAF provides lower levels of drug in the bloodstream, but higher levels within the cells where HIV-1 replicates. It was developed to help reduce some drug adverse effects. "While Genvoya is not recommended for patients with severe renal impairment, those with moderate renal impairment can take Genvoya," the FDA said.

Genvoya appears to be associated with less kidney toxicity and decreases in bone density than previously approved tenofovir-containing regimens. However, patients receiving Genvoya showed greater increases in serum lipids (total cholesterol and low-density lipoprotein) than those receiving other antiretroviral regimens in the studies, the FDA notes.

Genvoya carries a boxed warning stating that the drug can cause lactic acidosis and severe hepatomegaly with steatosis, both of which can be fatal. The boxed warning also states that Genvoya is not approved to treat chronic hepatitis B virus infection.

The most common adverse effect seen with Genvoya is nausea. Serious adverse effects include new or worsening renal impairment, decreased bone mineral density, fat redistribution, and immune reconstitution syndrome. Healthcare providers are advised to monitor patients for kidney and bone adverse effects. Genvoya should not be given with other antiretroviral products and may have drug interactions with a number of other commonly used medications.

European Union regulators recommended approval of Genvoya in September.

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